TCT 2024 | TRISCEND II: A New Hope in Percutaneous Tricuspid Valve Replacement

Advanced tricuspid regurgitation (TR) is a debilitating disease associated with heart failure and increased mortality. 

Edge-to-edge repair has been shown to improve both clinical condition and quality of life for patients; however, it has not demonstrated significant benefits in terms of mortality. It is important to note that these studies were conducted in patients with very severe disease, which likely affected the results.

Tricuspid valve replacement has proven to be a more effective alternative, improving quality of life, functional class, and survival compared to medical treatment.

In the TRISCEND II study, which is prospective and randomized, 392 patients with severe or higher tricuspid regurgitation were included. These patients showed symptoms or signs of TR or had been hospitalized for heart failure despite medical treatment. Of these, 259 patients underwent percutaneous tricuspid valve replacement (P-TVR), while the rest continued with medical treatment (MT).

The primary endpoint (PEP) was a composite that included all-cause death, need for right ventricular support, heart transplant, tricuspid surgery, or reintervention at one year of follow-up.

Read also: TCT 2024 – TAVR UNLOAD: Moderate Aortic Stenosis with Ventricular Function Deterioration.

The groups were well balanced in terms of baseline characteristics: the mean age was 78 years, 75% of subjects were women, the body mass index was 26, and the STS mortality score was 7% for valve repair and 10% for replacement. The average EuroScore was 5.4%. Regarding comorbidities, 20% had ascites, 10% had liver impairment, and 38% had previously required hospitalization for heart failure. Additionally, 90% had hypertension, 17% had chronic obstructive pulmonary disease (COPD), 57% had renal impairment, 15% had undergone myocardial revascularization surgery, 12% had a history of myocardial infarction, and 38% had a pacemaker or automated implantable cardioverter defibrillator (AICD).

The most common cause of TR was secondary (73%), followed by primary (14%) and mixed causes in lesser proportions. Severe TR was present in 47% of patients, torrential in 30%, and massive in the remaining cases. The average pulmonary artery systolic pressure was 38 mmHg, and the ejection fraction was 54%.

The PEP favored P-TVR (hazard ratio [HR]: 2.02; 95% confidence interval [CI]: 1.56 to 2.62; P<0.001). All-cause mortality was lower in the P-TVR group, but the difference did not reach statistical significance (12.5% vs. 14.8%). Heart failure rehospitalizations presented similar results.

Read also: TCT 2024 – EVOLVED Trial: Severe Aortic Stenosis and Myocardial Fibrosis.

The need for a permanent pacemaker was higher in patients who underwent P-TVR (17.4% vs. 2.3%).

In the P-TVR group, there was a significant improvement in functional class, quality of life, and the 6-minute walk test. Echocardiographic analysis showed a sustained reduction in TR, with 73% of subjects showing no or minimal regurgitation, and 23% showing mild regurgitation.

Conclusion

Transcatheter tricuspid valve replacement was superior to medical treatment in the composite primary endpoint, mainly due to improvements in symptoms and patient quality of life.

Original Title: Transcatheter Valve Replacement in Severe  Tricuspid Regurgitation. TRISCEND II Trial. 

Reference: R.T. Hahn, et al. NEJM DOI: 10.1056/NEJMoa2401918.